Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

NCT ID: NCT04217694

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2024-08-12

Brief Summary

This early phase I trial studies the feasibility of giving memantine for the reduction of cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors. Memantine may reduce the effects of radiation therapy on memory and thinking.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT.

SECONDARY OBJECTIVE:

I. To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.

EXPLORATORY OBJECTIVES:

I. To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT.

II. To compare the change in NCF between baseline and the end of RT, 3,and 6 months after RT using both neuropsychological testing and the CogState exam.

III. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation.

IV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing.

V. Disease-free (of primary tumor) and overall survival.

OUTLINE:

Patients receive memantine orally (PO) BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.

After completion of study, patients are followed up periodically.

Conditions

Malignant Central Nervous System Neoplasm; Primary Central Nervous System Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prevention (memantine, CogState)

Patients receive memantine PO BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.

Group Type: EXPERIMENTAL

Cogstate Assessment Battery

Intervention Type: BEHAVIORAL

Complete CogState testing

Memantine

Intervention Type: DRUG

Given PO

Memantine Hydrochloride

Intervention Type: DRUG

Given PO

Interventions

Cogstate Assessment Battery

Complete CogState testing

Intervention Type: BEHAVIORAL

Memantine

Given PO

Intervention Type: DRUG

Memantine Hydrochloride

Given PO

Intervention Type: DRUG

Other Intervention Names

Ebixia; Namenda

Eligibility Criteria

Inclusion Criteria

• Receiving intracranial radiation for a primary central nervous system (CNS) malignancy
• Histological or radiologic confirmation of intracranial disease
• Able to use the computer for CogState assessment battery
• Normal serum creatinine per institutional normal limits (obtained =< 35 days prior to study entry)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (obtained =< 35 days prior to study entry)
• Aspartate transaminase (AST) AND alanine transaminase (ALT) =< 2.5 x ULN
• Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17
• Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception

Exclusion Criteria

• Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors

• Note: A patient with grade IV tumors of other histology can participate in the study if they meet all other criteria
• Any prior intracranial radiation
• Any contraindication or allergy to memantine
• Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine)

• Note: occasional use as a sleep aid or as needed for anxiety or nausea is allowed
• Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia N. Laack, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2019-08538

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC1911

Identifier Type: OTHER

Identifier Source: secondary_id

19-004245

Identifier Type: OTHER

Identifier Source: secondary_id

MC1911

Identifier Type: -

Identifier Source: org_study_id